Actively Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
600
Participants Needed
169
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating nipocalimab compared to placebo in adults with moderate to severe Systemic Lupus Erythematosus (SLE), a chronic condition where the immune system attacks healthy tissues causing inflammation in various organs. This Phase 3 study aims to measure how well nipocalimab works using the SLE Responder Index (SRI)-4 response at Week 52 as the primary outcome. Participants will be randomly assigned to receive either nipocalimab or placebo along with standard care treatments during a 52-week double-blind period. After Week 52, eligible participants from both groups can join an open-label extension where they will receive nipocalimab until Week 156 or until the treatment is stopped. Throughout the study, participants will have regular assessments including physical exams, medical history reviews, vital signs, ECGs, and disease activity scoring. Researchers will track responses such as disease activity, joint pain, fatigue, and flare status at Week 52. Safety monitoring will continue during the extension period, with total participation lasting up to about three years.
CONDITIONS
Brief Title
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable based on physical exam, medical history, vital signs, and ECG at screening
- Clinical diagnosis of systemic lupus erythematosus (SLE) for at least 24 weeks using EULAR/ACR criteria
- SLEDAI-2K score of 6 or higher and clinical SLEDAI-2K score of 4 or higher at screening and Week 0, excluding lupus headache, alopecia, and organic brain syndrome
- Negative serum beta hCG test at screening and negative urine beta hCG test at Week 0 for women of childbearing potential
- At least 1 BILAG-2004 A score or 2 BILAG-2004 B scores at screening
You will not qualify if you...
- History of severe, progressive, or uncontrolled disorders affecting liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal systems, hypertension, or other uncontrolled autoimmune diseases
- Unstable or progressive SLE likely requiring therapy escalation beyond allowed background medications
- Confirmed or suspected immunodeficiency not related to SLE treatment, or family history of congenital immunodeficiency unless confirmed absent
- Previous severe immediate hypersensitivity reaction such as anaphylaxis to therapeutic proteins
- Known or suspected allergies or intolerance to nipocalimab, its excipients, or placebo excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive nipocalimab or placebo along with standard of care treatments during the double-blind treatment period.
Visits scheduled regularly during the 52 weeks
Duration - Up to 104 weeks (until Week 156 total or study discontinuation)
Eligible participants may continue receiving nipocalimab during the open-label long-term extension period after Week 52.
Visits scheduled regularly during the long-term extension period
Trial Site Locations
Total: 169 locations
1
David S Hallegua MD A Professional Corporation
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Hemet, California, United States, 92543
Actively Recruiting
3
Advanced Medical Research
La Palma, California, United States, 90623
Actively Recruiting
4
Solace Clinical Research California
Tustin, California, United States, 92780
Actively Recruiting
5
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States, 91786
Actively Recruiting
6
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Actively Recruiting
7
Clinical Research of West Florida 1
Clearwater, Florida, United States, 33765
Actively Recruiting
8
Avanti Clinical Research Corp
Hialeah, Florida, United States, 33013
Actively Recruiting
9
LeJenue Research Associates PLLC
Miami, Florida, United States, 33126
Actively Recruiting
10
Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States, 33014
Actively Recruiting
11
Floridian Clinical Research LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
12
Clinical Research of West Florida
Tampa, Florida, United States, 33606
Actively Recruiting
13
Atlanta Research Center for Rheumatology
Marietta, Georgia, United States, 30060
Actively Recruiting
14
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States, 60527
Actively Recruiting
15
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
16
Revive Research Institute
Sterling Heights, Michigan, United States, 48313
Actively Recruiting
17
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
18
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28211
Actively Recruiting
19
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States, 28304 4422
Actively Recruiting
20
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
21
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
22
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
23
Arthritis and Rheumatology Research Institute
Allen, Texas, United States, 75013
Actively Recruiting
24
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Actively Recruiting
25
R and H Clinical Research
Katy, Texas, United States, 77449
Actively Recruiting
26
Southwest Rheumatology Research LLC
Mesquite, Texas, United States, 75150
Actively Recruiting
27
Texas Rheumatology Research Institute LLC
Plano, Texas, United States, 75024
Actively Recruiting
28
Epic Medical Research 1
Red Oak, Texas, United States, 75154
Actively Recruiting
29
Fort Bend Rheumatology Associates PLLC
Sugar Land, Texas, United States, 77479
Actively Recruiting
30
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina, C1406AGA
Actively Recruiting
31
Centro Privado de Medicina Familiar
Buenos Aires, Argentina, C1417EYG
Actively Recruiting
32
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, Argentina, C1055
Actively Recruiting
33
Arsema
Ciudad de Buenos Aires, Argentina, C1427
Actively Recruiting
34
Global Psy Asociacion Civil
La Plata, Argentina, B1904
Actively Recruiting
35
Cer Instituto Medico
Quilmes, Argentina, B1878DVB
Actively Recruiting
36
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina, B1878GEG
Actively Recruiting
37
MR Medicina Reumatologica
San Fernando, Argentina, B1646GHP
Actively Recruiting
38
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, Argentina, T4000AXL
Actively Recruiting
39
Footscray Hospital, Western Health
Footscray, Australia, 3011
Actively Recruiting
40
Ipswich Hospital
Ipswich, Australia, 4305
Actively Recruiting
41
Hospital das Clinicas - UFG
Goiânia, Brazil, 74605-020
Actively Recruiting
42
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, Brazil, 36010 570
Actively Recruiting
43
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
44
LMK Servicos Medicos S S
Porto Alegre, Brazil, 90480 000
Actively Recruiting
45
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90560032
Actively Recruiting
46
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil, 90610 000
Actively Recruiting
47
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, Brazil, 40150 150
Actively Recruiting
48
Fundacao do ABC Centro Universitario FMABC
Santo André, Brazil, 09060 870
Actively Recruiting
49
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, Brazil, 15090 000
Actively Recruiting
50
ESHO Empresa De Servicos Hospitalares S A
São Paulo, Brazil, 01232 010
Actively Recruiting
51
CEDOES Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda
Vitória, Brazil, 29055 450
Actively Recruiting
52
MC Medtech Services Ltd
Haskovo, Bulgaria, 6304
Actively Recruiting
53
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, Bulgaria, 4004
Actively Recruiting
54
Diagnostic consulting center 1 Ruse EOOD
Rousse, Bulgaria, 7002
Actively Recruiting
55
Diagnostic-Consultative Center (DCC) Aleksandrovska
Sofia, Bulgaria, 1431
Actively Recruiting
56
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Actively Recruiting
57
Military Medical Academy Multiprofile Hospital for Active Treatment Sofia
Sofia, Bulgaria, 1606
Actively Recruiting
58
UMHAT 'Sveti Ivan Rilsky'
Sofia, Bulgaria, 1612
Actively Recruiting
59
University Multi Profile Hospital for Active Treatment UMHAT St. Marina
Varna, Bulgaria, 9010
Actively Recruiting
60
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
61
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, China, 610041
Actively Recruiting
62
Dongguan People s Hospital
Dongguan, China, 523109
Actively Recruiting
63
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, China, 311608
Actively Recruiting
64
Jinhua municipal central hospital
Jinhua, China, 321013
Actively Recruiting
65
Shandong Jining No.1 People's Hospital
Jining, China, 272073
Actively Recruiting
66
Linfen Central Hospital
Linfen, China, 041000
Actively Recruiting
67
Ningbo medical center lihuili hospital
Ningbo, China, 315041
Actively Recruiting
68
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
Shanwei, China, 516601
Actively Recruiting
69
Second Affiliated Hospital, SooChow University
Suzhou, China, 215004
Actively Recruiting
70
Shanxi Bethune Hospital
Taiyuan, China, 030032
Actively Recruiting
71
Revimex Pro s r o
Karvina Frystat, Czechia, 733 01
Actively Recruiting
72
Revmatologicky ustav
Prague, Czechia, 128 50
Actively Recruiting
73
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
74
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
75
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
76
Northern Clinical Trial Coordinators
Oulu, Finland, 90150
Actively Recruiting
77
Centre Hospitalier Le Mans
Le Mans, France, 72037
Actively Recruiting
78
CHU Toulouse - Hopital de Rangueil
Toulouse, France, 31400
Actively Recruiting
79
Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
80
CAIR Heidelberg
Heidelberg, Germany, 69121
Actively Recruiting
81
Klinikum der Universitaet Muenchen
München, Germany, 80336
Actively Recruiting
82
Medicover Muenchen Ost MVZ
München, Germany, 81667
Actively Recruiting
83
Laiko General Hospital of Athens
Athens, Greece, 115 27
Actively Recruiting
84
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, Greece, 12461
Actively Recruiting
85
University General Hospital of Heraklion
Heraklion, Greece, 715 00
Actively Recruiting
86
General University Hospital Of Larissa
Larissa, Greece, 41110
Actively Recruiting
87
Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
Budapest, Hungary, 1027
Actively Recruiting
88
Vita Verum Medical Egeszsegugyi Szolgaltato Bt
Székesfehérvár, Hungary, 8000
Actively Recruiting
89
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprém, Hungary, 8200
Actively Recruiting
90
Obudai Egeszsegugyi Centrum Kft
Zalaegerszeg, Hungary, 8900
Actively Recruiting
91
Bnai Zion Medical Center
Haifa, Israel, 31048
Actively Recruiting
92
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
93
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
94
Hadassah Ein-Qarem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
95
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
96
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
97
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
98
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy, 60126
Actively Recruiting
99
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
100
Tokai University Hospital
Isehara, Japan, 259-1193
Actively Recruiting
101
Shinkenko Clinic
Naha, Japan, 900 0015
Actively Recruiting
102
Kitano Hospital
Osaka, Japan, 530-8480
Actively Recruiting
103
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Actively Recruiting
104
St. Luke's International Hospital
Tokyo, Japan, 104 8560
Actively Recruiting
105
Hospital Sultan Ismail
Johor Bahru, Malaysia, 81100
Actively Recruiting
106
Hospital Sultanah Nur Zahirah
Kuala, Malaysia, 20400
Actively Recruiting
107
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
108
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
109
Sunway Medical Centre
Petaling Jaya, Malaysia, 47500
Actively Recruiting
110
Hospital Taiping
Taiping, Malaysia, 34000
Actively Recruiting
111
Haukeland University Hospital
Bergen, Norway, 5009
Actively Recruiting
112
Oslo universitetssykehus HF, Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
113
Stavanger University Hospital
Stavanger, Norway, 4011
Actively Recruiting
114
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, Poland, 85 065
Actively Recruiting
115
Jan Biziel's University Hospital
Bydgoszcz, Poland, 85 168
Actively Recruiting
116
Nzoz Bif Med
Bytom, Poland, 41 902
Actively Recruiting
117
Provita Sp z o o
Katowice, Poland, 40 611
Actively Recruiting
118
Malopolskie Badania Kliniczne Sp z o o
Krakow, Poland, 30-002
Actively Recruiting
119
NZOZ Lecznica MAK MED S C
Nadarzyn, Poland, 05 830
Actively Recruiting
120
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Poland, 67 100
Actively Recruiting
121
Twoja Przychodnia Poznanskie Centrum Medyczne
Poznan, Poland, 60-324
Actively Recruiting
122
Innova Clinic sp z o o
Płońsk, Poland, 09 100
Actively Recruiting
123
MICS Centrum Medyczne Warszawa
Warsaw, Poland, 00-874
Actively Recruiting
124
Rheuma Medicus Sp z o o
Warsaw, Poland, 02 118
Actively Recruiting
125
Uls Almada Seixal - Hosp. Garcia de Orta
Almada, Portugal, 2805 267
Actively Recruiting
126
Uls Sao Jose - Hosp. Curry Cabral
Lisbon, Portugal, 1069 166
Actively Recruiting
127
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal, 1649 028
Actively Recruiting
128
Ulsam - Hosp. Conde de Bertiandos
Ponte de Lima, Portugal, 4990-041
Actively Recruiting
129
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED
Brasov, Romania, 500283
Actively Recruiting
130
Spitalul Clinic Sfanta Maria
Bucharest, Romania, 011172
Actively Recruiting
131
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania, 400006
Actively Recruiting
132
Medisof Diagnostic S R L
Craiova, Romania, 200347
Actively Recruiting
133
Spitalul Clinic Judetean de Urgenta Bihor
Oradea, Romania, 410469
Actively Recruiting
134
Medbanat s r l
Timișoara, Romania, 300766
Actively Recruiting
135
MEDMAN s.r.o.
Martin, Slovakia, 036 01
Actively Recruiting
136
Narodny Ustav Reumatickych Chorob
Piešťany, Slovakia, 921 12
Actively Recruiting
137
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
138
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea, 13620
Actively Recruiting
139
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
140
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
141
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
142
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain, 8026
Actively Recruiting
143
Hosp. Gral. Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
144
Hosp. Univ. Infanta Leonor
Madrid, Spain, 28031
Actively Recruiting
145
Complejo Hosp de Navarra - Hosp de Navarra
Pamplona, Spain, 31008
Actively Recruiting
146
Hosp. Univ. Marques de Valdecilla
Santander, Spain, 39008
Actively Recruiting
147
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
148
Hosp. Univ. Rio Hortega
Valladolid, Spain, 47012
Actively Recruiting
149
NTU Biomedical Park Hospital
Hsinchu, Taiwan, 302058
Actively Recruiting
150
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813414
Actively Recruiting
151
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
152
National Taiwan University Hospital
Taipei, Taiwan, 10043
Actively Recruiting
153
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
154
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
155
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Actively Recruiting
156
Ramathibodi Hospital Mahidol University
Bangkok, Thailand, 10400
Actively Recruiting
157
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
158
Ankara University Medical Faculty
Ankara, Turkey (Türkiye), 06050
Actively Recruiting
159
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
160
Firat University Hospital
Elâzığ, Turkey (Türkiye), 23200
Actively Recruiting
161
Sanko Universitesi Hastanesi
Gaziantep, Turkey (Türkiye), 27090
Actively Recruiting
162
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye), 34899
Actively Recruiting
163
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye), 42080
Actively Recruiting
164
Newcastle Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
165
Peterborough City Hospital
Peterborough, United Kingdom, PE3 9GZ
Actively Recruiting
166
Royal Berkshire Hospital
Reading, United Kingdom, RG1 5LE
Actively Recruiting
167
Southampton University Hospital
Southampton, United Kingdom, SO16 6HU
Actively Recruiting
168
Haywood Hospital
Stoke-on-Trent, United Kingdom, ST6 7AG
Actively Recruiting
169
Great Western Hospital
Swindon, United Kingdom, SN3 6BB
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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